| { |
| "dataset": "fda-facility-compliance-intelligence", |
| "title": "FDA Facility Compliance Intelligence", |
| "version": "1.0.0", |
| "source": "FDA Data Dashboard API + openFDA (U.S. Government public domain)", |
| "record_count": 132080, |
| "field_count": 25, |
| "fields": [ |
| { |
| "name": "fei_number", |
| "type": "string", |
| "description": "FDA Facility Establishment Identifier (FEI) \u2014 the cross-source join key." |
| }, |
| { |
| "name": "legal_name", |
| "type": "string", |
| "description": "Facility legal name, taken from its most recent inspection record." |
| }, |
| { |
| "name": "city", |
| "type": "string", |
| "description": "Facility city (most recent inspection record)." |
| }, |
| { |
| "name": "state", |
| "type": "string", |
| "description": "Facility state/province (most recent inspection record)." |
| }, |
| { |
| "name": "country", |
| "type": "string", |
| "description": "Facility country (most recent inspection record)." |
| }, |
| { |
| "name": "product_types", |
| "type": "list<string>", |
| "description": "Distinct FDA product areas inspected at this facility (e.g. Drugs, Devices, Foods)." |
| }, |
| { |
| "name": "total_inspections", |
| "type": "integer", |
| "description": "Count of distinct FDA inspections on record for this facility." |
| }, |
| { |
| "name": "oai_count", |
| "type": "integer", |
| "description": "Inspections classified Official Action Indicated (OAI) \u2014 the most serious outcome." |
| }, |
| { |
| "name": "vai_count", |
| "type": "integer", |
| "description": "Inspections classified Voluntary Action Indicated (VAI)." |
| }, |
| { |
| "name": "nai_count", |
| "type": "integer", |
| "description": "Inspections classified No Action Indicated (NAI)." |
| }, |
| { |
| "name": "most_recent_inspection_date", |
| "type": "date", |
| "description": "End date of the facility's most recent inspection." |
| }, |
| { |
| "name": "most_recent_classification", |
| "type": "string", |
| "description": "Classification of the most recent inspection (full text)." |
| }, |
| { |
| "name": "most_recent_classification_code", |
| "type": "string", |
| "description": "Classification code of the most recent inspection (NAI/VAI/OAI)." |
| }, |
| { |
| "name": "warning_letter_count", |
| "type": "integer", |
| "description": "Count of Warning Letter compliance actions issued to this FEI." |
| }, |
| { |
| "name": "recall_count", |
| "type": "integer", |
| "description": "Count of device + drug recalls attributed to this facility. Recalls carry no FEI, so they are matched by unambiguous 1:1 normalized firm name (see Methodology)." |
| }, |
| { |
| "name": "import_refusal_count", |
| "type": "integer", |
| "description": "Count of FDA import refusals recorded against this FEI." |
| }, |
| { |
| "name": "total_citations", |
| "type": "integer", |
| "description": "Total inspection citations (483 observations) recorded across all inspections." |
| }, |
| { |
| "name": "distinct_cfr_codes", |
| "type": "integer", |
| "description": "Number of distinct CFR codes cited across the facility's inspections." |
| }, |
| { |
| "name": "repeat_citation_flag", |
| "type": "boolean", |
| "description": "True if the same CFR code was cited across 2+ distinct inspections." |
| }, |
| { |
| "name": "most_cited_cfr", |
| "type": "string", |
| "description": "The CFR code cited across the most distinct inspections at this facility." |
| }, |
| { |
| "name": "ever_escalated_to_wl", |
| "type": "boolean", |
| "description": "True if any inspection at this facility was followed by a Warning Letter (or stronger)." |
| }, |
| { |
| "name": "fastest_escalation_days", |
| "type": "integer", |
| "description": "Shortest observed gap (days) from an inspection end to a subsequent Warning Letter; null if none." |
| }, |
| { |
| "name": "has_510k_clearance", |
| "type": "boolean", |
| "description": "True if the facility holds at least one 510(k) device clearance." |
| }, |
| { |
| "name": "count_510k", |
| "type": "integer", |
| "description": "Number of 510(k) device clearances linked to this facility's FEI." |
| }, |
| { |
| "name": "facility_risk_score", |
| "type": "float", |
| "description": "Composite regulatory-risk score, 0\u2013100 (higher = more regulatory exposure). Heuristic, not an official FDA designation. Formula: min(100, oai_count*15 + warning_letter_count*20 + recall_count*10 + min(import_refusal_count*2,20) + repeat_citation_flag*10 + (recent OAI)*15 + recency_factor)." |
| } |
| ] |
| } |
|
|
